{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-10587", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220312", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220211", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220312", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210824", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "971765", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220312", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-05", "catalog_number": "480440", "lot_number": "L90210824 0350", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)230831(10)L90210824", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220312", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220211", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13750434", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220211", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "291953054", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION, ALTHOUGH IT IS EXPECTED TO BE RETURNED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG OF THE SYNCHOSEAL (PART # 480440-05; /LOT # L90210824-0350) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2022 ON SYSTEM (B)(4). THIS IS A SINGLE USE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWED NO ADDITIONAL COMPLAINT RELATED TO THIS PRODUCT. SIX PHOTOS WERE SENT BY THE ROBOTICS COORDINATOR TO ISI AND WERE REVIEWED BY A FAILURE ANALYSIS ENGINEER. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, IT WAS ALLEGED A WASHER FROM THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE WASHER DURING THE SAME PROCEDURE USING A LAPAROSCOPIC GRASPER." }, { "mdr_text_key": "291953055", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, A WASHER FROM THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE WASHER, BUT WAS NOT SURE IF A SCREW WAS ATTACHED TO THE WASHER. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. ON 16-FEB-2022, THE ROBOTICS COORDINATOR SENT INTUITIVE SURGICAL, INC. (ISI) PHOTOS OF THE INSTRUMENT AND THE WASHER. THE PHOTOS WERE FORWARDED TO FAILURE ANALYSIS ENGINEER (FAE) FOR REVIEW. FROM THE PHOTOS, FAE STATED IT LOOKED LIKE ALL COMPONENTS WERE RETRIEVED. THE PIVOT PIN WAS STILL WITHIN THE JAWS, AND THE WASHER DISLODGED AND WAS RETRIEVED IN ONE PIECE. ISI PASSED THE FAE'S INFORMATION TO THE CUSTOMER. ON 22-FEB-2022, ISI OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE ITEM (WASHER) WAS RETRIEVED IN THE SAME PROCEDURE. THEY USED A LAPAROSCOPIC GRASPER TO RETRIEVE THE WASHER. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE ITEM. AN X-RAY WAS PERFORMED TO VERIFY THAT EVERYTHING WERE RETRIEVED. THE SURGEON BELIEVES THE INSTRUMENT BROKE DUE TO A PRODUCT MALFUNCTION. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING WAS OUT OF THE ORDINARY. THE INSTRUMENT WAS ONLY IN USE FOR 2 MINUTES BEFORE THE ISSUE OCCURRED, BUT IT FUNCTIONED AS EXPECTED. THE SURGEON WAS DOING A GREATER CURVATURE DISSECTION WHEN THE WASHER FELL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD OBJECT. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT HAS NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS DUE TO THIS ISSUE. THE INSTRUMENT AND THE WASHER WILL BOTH BE RETURNED TO ISI." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }